Osteo Arthritis KneeNCT03476382
The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.
A study testing Ultrasound Bone Growth Stimulator in people with Osteo Arthritis Knee, run by Coastal Carolinas Integrated Medicine at 1 site in United States.
Trial summary
The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone disease where the joint changes are secondary, and bone growth stimulators function to decrease intraosseous venous congestion and remodel bone, then there is a potential benefit for the treatment of osteoarthritis of the knee… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Ultrasound Bone Growth Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects must have diagnosis of osteoarthritis of the knee with radiographic evidence of joint space narrowing, Kellgren-Lawrence Classification grade Grade 3 or 4.
- Subjects must discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.
- Subjects must speak English.
- Subject must be willing and able to sign an informed consent document.
- Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.
Who cannot join
- Subjects with a diagnosis of inflammatory arthritis such as rheumatoid arthritis, gout, joint infection, Lyme disease, or systemic lupus erythematosus.
- Subjects with a diagnosis of secondary arthritis such as acromegaly, Charcot's arthropathy, hemochromatosis, or Wilson's disease.
- Subjects who have had an injury to the index knee within 6 months of starting treatment.
- Subjects must NOT have had arthroscopy within 8 weeks of starting treatment.
- Subjects must NOT have had viscosupplementation within 8 weeks of starting treatment.
- Subjects who plan to have surgery on the target knee within the study period.
Show all 9Show fewer
- Subjects with surgical metallic hardware in the target knee.
- Subjects who are unwilling or unable to adhere to the follow up schedule and procedures.
- Subjects who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Coastal Carolinas Integrated Medicine
Supply, North Carolina, 28462
About this study
The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone disease where the joint changes are secondary, and bone growth stimulators function to decrease intraosseous venous congestion and remodel bone, then there is a potential benefit for the treatment of osteoarthritis of the knee with bone growth stimulators.
Read the detailed description
The hypothesis of this study is based on the knowledge that osteoarthritis of the knee is primarily a bone disease, and the joint changes are secondary. Bone growth stimulators function to alleviate intraosseous venous congestion through the process of bone remodeling. The working hypothesis is that alleviation of intraosseous venous congestion leads to improved delivery of nutrition to the tissue to support the health of the bone with improvement in biomechanics leading to clinical improvement. Venous congestion is measured with intraosseous pressure. Additional objective evidence of biomarkers of bone metabolism as well as measurements of subjective questionnaires can provide evidence of benefit.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Ultrasound Bone Growth Stimulator
- Keywords
- Osteoarthritis, Knee, Bone Growth Stimulators, Rheumatic Diseases, Musculoskeletal Diseases, Joint Diseases, Arthritis
- Medical subject headings
- Osteoarthritis, Rheumatic Diseases, Musculoskeletal Diseases, Joint Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Bone Growth StimulatorDevice
Active device emits ultrasound signals.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants use active Ultrasound Bone Growth Stimulator device according to Investigational Protocol. Receives: Device: Ultrasound Bone Growth Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraosseous Venous Congestion measured by Intraossous Pressure.
Statistically significant decrease in intraosseous pressure following treatment.
Measured: 14 weeks
Secondary outcomes (3)
Human Matrix Metalloproteinase-3 (MMP-3)
Statistically significant decrease in the biomarker MMP-3
Measured: 14 weeks
C- telopeptide.
Statistically significant decrease in the biomarker C- telopeptide.
Measured: 14 weeks
Change over time in WOMAC score.
The primary outcome variables are a statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start9 Apr 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coastal Carolinas Integrated Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Willeford, MD, Study chair, Coastal Carolinas Integrated MedicineSierra Willeford, Principal investigator, Coastal Carolinas Integrated MedicineBreanna Willeford, Principal investigator, Coastal Carolinas Integrated Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476382
- Sponsor's protocol ID
- CCIM 0001
- Status last verified
- Jan 2019
- First submitted
- 18 Mar 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT03476382
- Acronym / sponsor ID
- CCIM 0001
- Conditions
- Osteo Arthritis Knee
- Keywords
- Osteoarthritis, Knee, Bone Growth Stimulators, Rheumatic Diseases, Musculoskeletal Diseases, Joint Diseases, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coastal Carolinas Integrated MedicineUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone disease where the joint changes are secondary, and bone growth stimulators function to decrease intraosseous venous congestion and remodel bone, then there is a potential benefit for the treatment of osteoarthritis of the knee with bone growth stimulators.
Detailed description
The hypothesis of this study is based on the knowledge that osteoarthritis of the knee is primarily a bone disease, and the joint changes are secondary. Bone growth stimulators function to alleviate intraosseous venous congestion through the process of bone remodeling. The working hypothesis is that alleviation of intraosseous venous congestion leads to improved delivery of nutrition to the tissue to support the health of the bone with improvement in biomechanics leading to clinical improvement. Venous congestion is measured with intraosseous pressure. Additional objective evidence of biomarkers of bone metabolism as well as measurements of subjective questionnaires can provide evidence of benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Ultrasound Bone Growth StimulatorParticipants use active Ultrasound Bone Growth Stimulator device according to Investigational Protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have diagnosis of osteoarthritis of the knee with radiographic evidence of joint space narrowing, Kellgren-Lawrence Classification grade Grade 3 or 4.
- Subjects must discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.
- Subjects must speak English.
- Subject must be willing and able to sign an informed consent document.
- Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.
Key exclusion criteria (9 listed)
- Subjects with a diagnosis of inflammatory arthritis such as rheumatoid arthritis, gout, joint infection, Lyme disease, or systemic lupus erythematosus.
- Subjects with a diagnosis of secondary arthritis such as acromegaly, Charcot's arthropathy, hemochromatosis, or Wilson's disease.
- Subjects who have had an injury to the index knee within 6 months of starting treatment.
- Subjects must NOT have had arthroscopy within 8 weeks of starting treatment.
- Subjects must NOT have had viscosupplementation within 8 weeks of starting treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Bone Growth StimulatorActive device emits ultrasound signals. | Device | Experimental Group |
Primary outcome
Intraosseous Venous Congestion measured by Intraossous Pressure.
Time frame: 14 weeks
Statistically significant decrease in intraosseous pressure following treatment.
3 secondary outcomes
Human Matrix Metalloproteinase-3 (MMP-3)
Time frame: 14 weeks
C- telopeptide.
Time frame: 14 weeks
Change over time in WOMAC score.
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Willeford, MD study chair
Coastal Carolinas Integrated Medicine
Sierra Willeford principal investigator
Coastal Carolinas Integrated Medicine
Breanna Willeford principal investigator
Coastal Carolinas Integrated Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Bone Growth Stimulator in people with Osteo Arthritis Knee, run by Coastal Carolinas Integrated Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraosseous Venous Congestion measured by Intraossous Pressure. (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.